Several New Stem Cell Clinical Trials Poised to Begin in Two to Three Years

One of the more exciting aspects of FFB’s recent annual conference, VISIONS 2013, was the news on the clinical development of several emerging stem cell therapies. The field has picked up a lot of steam, with many new human studies of stem-cell treatments anticipated to begin in 2014 and 2015.

What’s particularly noteworthy is that some of these trials will be for people with retinitis pigmentosa (RP) — a population not yet included in human stem-cell studies. Also, investigators will evaluate new types of cells and new, innovative approaches to implanting them.

Here’s a review of three of the stem-cell clinical studies on the horizon:

In June, the Japanese Health Ministry gave approval to the Riken Institute to launch a clinical trial of sheets of retinal pigment epithelial (RPE) cells for the treatment of wet age-related macular degeneration (AMD). The study is planned for 2014.

The sheets will replace native RPE cells damaged by leaky blood vessels, which are the hallmark of wet AMD. RPE cells play a critical role in supporting photoreceptors, the cells that make vision possible.

For the first time in a human study, the researchers will produce RPE cells from induced pluripotent stem cells (iPSC) — stem cells derived by turning back the development clock on a small sample of skin taken from the patient. The stem cells are then coaxed forward to become RPE. Because the cells come from the patient, there’s less chance of immune rejection.

David Gamm, M.D., Ph.D., of the University of Wisconsin-Madison, said that transplanting sheets of RPE cells — rather than injecting a bolus or a clump of cells — was likely to produce better results, because RPE cells naturally occur as a layer in the retina. He believes that sheets of cells have a better chance to integrate and function normally.

By the way, Dr. Gamm, in collaboration with Dennis Clegg, Ph.D., of the University of California, Santa Barbara, is receiving Foundation funding to develop a patch of cells — comprised of photoreceptors and RPE cells — for treating retinal diseases. While his work is still a few years away from the clinic, it is very promising, because so many retinal diseases affect both of these cell types.

UC Irvine: Retinal Progenitor Therapy for Reactivating the Retina

Henry Klassen, M.D., Ph.D., of the University of California, Irvine, and a former recipient of a Foundation Career Development Award, is planning to launch a clinical trial of a stem-cell therapy for people with RP. He hopes to begin the study in late 2014 or early 2015.

His treatment involves the transplantation of progenitor stem cells — cells that have partially developed into retinal cells. Based on results from his lab studies, he believes the progenitors will rescue and reactivate dormant cones in the retinas of people with early- and late-stage disease.

Not only is Dr. Klassen an outstanding scientist, he’s resourceful and collaborative — qualities that will undoubtedly enhance his chances of success. He obtained a $17.3 million grant from the California Institute of Regenerative Medicine, a legislative initiative providing $3 billion in funding over 10 years for stem cell research in facilities throughout California. Dr. Klassen’s project was also accepted into the Therapeutics for Rare and Neglected Diseases (TRND) program established by the National Institutes of Health to speed the development of new treatments for rare and neglected diseases. TRND will provide him with specialized expertise and resources to help advance his efforts.

One of the more ambitious stem-cell treatments nearing human study is being developed by ReNeuron, a company from the United Kingdom. Its retinal progenitor treatment replaces photoreceptors lost to retinitis pigmentosa. When transplanted in the retina, ReNeuron researchers believe that the partially developed cells will mature into fully functional photoreceptors. The company hopes to launch a clinical trial, probably in the U.K., in the next year or two.

Previously funded by the Foundation, Michael Young, Ph.D., of Schepens Eye Institute, Massachusetts Eye and Ear Infirmary, conducted much of the research making this treatment approach possible. His work included the development of a biodegradable scaffold for growing and organizing the cells prior to transplantation. The structure increases the chances of survival and integration of the therapeutic cells.

But Wait — There’s More

Fortunately, there are far too many promising stem-cell research efforts to cover in one post, so here are links to other retinal-disease projects:

The purpose of the blog was to highlight clinical trials that are due to begin in the near future. We have previously highlighted ACT’s work in several articles and blog posts. Here are a few of those:

We are encouraged by the report on the one patient you referenced, but the report is just for one patient. ACT itself cautions that conclusions should not be drawn based on short-term results for one patient. We will be sure to report on ACT’s published statement/report on results for all its treated patients. That will be much more telling than a single anecdote.

Unfortunately, Optic Nerve Damage is not a disease that we specialize in funding research for and so we ar enot the best organization to comment on its research progress. We would encourage you contact or to check out the site of the National Eye Institute.

At the link below, the eye institute provides contact information for other resources and organizations that can assist you and tell you more about Optic Nerve Damage specifically.

my son was hit by a car and lost his vision when he was 5. doctors told us it was the optic nerves that were damaged. he is 12 now and still prays that somehow he will be able to see again someday. would love to hear more about any new science. i feel blessed that he is so young, and with science being so advanced now, i know he WILL see again. we appreciate all that is being done to help and pray god guides these hands that are testing different areas. thank u.

Raye, thank you so much for your comment and for your support. As the blog post states, we have yet to see what we will find out as a result of these trials, but like you, we are hopeful that this research could provide a possible treatment for a variety of conditions. We wish you and your family the best during this time.

Sandy, I have the same question. We’re you ever able to find out any information? My son Michael suffered a TBI and his optic nerve has died as a result. He is 20 years old and completely blind. We have been to china for stem cell therapies but no results. Please email me at jtoto322@yahoo.com to share your findings. I would love to hear your progress and share ours.

Hi, I was wondering if you ever got an answer to your question about trials for dead optic nerve treatment. My brother lost his sight 10 years ago due to traumatic brain trauma. His optic nerves are in tact but not functional. We are hoping trials would start soon, his last doctor told us treatments were being worked on but haven’t heard much more. Could u let me know if something comes along. Thanks-Brian butler

My husband participated in a NIH clinical trial in Margate, Florida. He has had optic nerve ischaemia in both eyes, and had limited vision. He had the procedure on July 1, 2014. His vision is improving, but slowly. However, it is better than before and appears that it will continue to improve. This was done by using his own stem cells, to see if they would repair damage to the optic nerves. We are hopeful. A friend of his had the same procedure in October, and is noticing improvement in his vision. Their optic nerves were not dead…..they were compressed, which limited the blood flow in the optic nerve.

I recently spoke to the Stem Cell Center at UC Berkeley. They also said clinical trials might start within 3 years but they couldn’t say where. I called on behalf of my good friend, Joe, whom I’ve known for 40 years. Joe has RP and has indicated a willingness to participate in clinical trials. Will the RP Foundation be following this and providing info on how to register or what criteria the researchers will be looking for in volunteers? A solution seems tantalizingly close!

There is a company in the United Kingdom called ReNeuron (http://www.reneuron.com/our-products) which is planning a clinical trial of a stem cell therapy for people with RP. They are planning to launch their study within a year, perhaps sooner. It is not clear if that study will take place in the U.S. and/or the U.K. Aside from the ReNeuron trial, the first stem cell clinical trials for people in the U.S. with RP are likely a few years away. The Foundation will announce details of these trials – including participation criteria – on our Web site when it becomes available.

Thank you so much for pushing ahead and not giving up on the light at the end of the tunnel. I pray everyday that a cure happens soon for my teenage son with
x-linked RP. It is through research and doctors like Samuel Jacobson at Scheie Eye Institute that give us hope. God Bless~

Sky, thanks for your comment. These trials are at different stages and are each focused in different areas. If there is one that you are interested in learning more about, or even participating in, we would recommend visiting http://www.clinicaltrials.gov and doing a search for the particular study. this website provides additional details and contact information for those conducting the study.

Thank you for trying, I hope there is a cure before I become blind because I’ve got very bad depression because of it and I really want to be able to see my kids and there kids, I know how bad my grandpa feels about not being able to see us

Our problem (my wife Carole) is her optic nerve went ischemic after a stroke which lodged an embolus in the artery feeding her optic nerve. Since she had only one good eye, she became totally blind six years ago.
Stem cell research to regenerate the optic nerve would be overwhelming for us!!

Dear Lillian, You will be happy to know that stem cell therapy is currently being evaluated for possible use in optic nerve damage. The research is slowly moving towards the clinic but will probably not be ready for clinical trials for a few more years. Dr. Dong Chen at Schepens’ Eye Institute is currently working in this area. To read more about his work, please see the following web link: http://www.schepens.harvard.edu/research-storychen/dong-feng-chen-md-phd/research-story.html

I am so happily excited that the research you are doing gives such hope. My two kids ages 16 and 18 have RP. They have had it passed to them through their fathers side of the family. I my self have 20/15 in both eyes, so I do not know how they are seeing things exactly. My daughter wanted to be a police officer until she found out this year she has signs of RT. With this research are you looking to completely restore the the cones back to “20/20” or can you predict? where can i go for more info. if possible may you please send me up-dates on the latest information concerning RP. Thank you for the hope my kids may have with this research. Blessings to your reach and understanding. THANK YOU

Thanks, Billie, for your inquiry. Here are a few comments/replies to your questions.

Most forms of retinitis pigmentosa (RP) affect peripheral and night vision first. So, children and young adults have more issues with seeing in dark settings or objects off to the side. They may not have trouble reading a book – or other tasks that require the ability to perceive details –
until later in life. Your kids may still have 20/20 vision (or relatively good acuity), and instead have trouble seeing at night. The severity and rate of progression of vision loss can vary from person to person, even within the same family.

There are many emerging treatments for RP, some of which may slow disease progression or others that may restore vision. We recommend you visit http://www.fightblindess.org and this blog regularly for information on the research. At fightblindness.org, you can also register to receive our newsletters.

It is also important that your family get care from a retinal specialist who is familiar with RP. If you call 1-800-683-5555, we can try to find an appropriate retinal specialist in your area.

My twin brother and I have been dealing with RP Since 3 years old. Now 36. This is a Godsend. Our heavenly Father ,Jesus our Lord and savior have the last say so. We will be cured. Our prayers have been answered. My RP people i know the struggle and the pain. The tears the running into things. Soon, very soon, you”re be driving, seeing stars in the night sky, seeing love ones and telling them thank you for guiding and helping me all these years sincerely appreciated every moment. But now I got this!!!

I very much appreciate the amount of hard work each team is putting in research. My husband is suffering from RP, his vision is deteriorating with his age but I am not giving up any hope and believe he will be able to see one day. Please keep me updated on your research results.

For those posting here: It seems these clinical trials target RPE and photoreceptor cells. From what I’ve read, RPE cell clinical trials are already underway. ACT has had some success implanting between 50,000 and 100,000 cells or so under the retina and restoring some vision or at least better visual acuity. RPE cells feed the other retina cells including photoreceptors. Photoreceptor stem/progenitor cell trials seem close with dr. klassen in Irvine CA, but I haven’t heard much about progress with ganglion cells. They’re the ones that carry the signal to and through the optic nerve and are important for already severely damaged retinas and optic nerves. I wonder how close they are to trials. I’d also like to hear about how we can help. Donations, awareness events, etc…

Hi every one .
My heartily prays and best wishes for all the people !
In Pakistan , I’ve been hearing since my childhood that there is no cure for RPE in the world and every time I came out crying from the hospital . I’m 30 of age now and have a very low tunnel vision . It seems that the m gonna be blind very soon . I have been facing too much pain and problems and wanna die now . Please tell me how can I be a part of three trials .

The first step is to obtain a specific diagnosis. You mentioned you had a problem with the optic nerve and retina. This could be any number of retinal diseases such as LCA, LHON, glaucoma, RP, etc. You should ask your doctor for the name of the disease. He or She should be able to provide you with this information. Once you have the specific diagnosis, I would be happy to help you try and find potential treatments. Thank you for your support.

I realy hope you find a cure for Glaucoma too. I’m only 51 and canot function anymore due to this terrible disease. I want to live a normal life and see things as they were.I have to stay home to be familiar with my surroundings. I’m very depressed. Once a fully member of society, now a wreck. Pls. speed up, because I don’t know how long I can stand this misserable life anymore.

Richard, please be assured that researchers are working hard to try and unravel the mysteries surrounding these diseases. The good news is that what scientists are learning from one disease is helping them with the design of treatments for other diseases. The drug Brimonidine was first approved for use in glaucoma but is now in human clinical trials for retinitis pigmentosa. You should see your ophthalmologist regularly to make sure your IOP is not too high.

i had a retinal detachment some years ago.i had surgery and after a year i got a cataract.so i had another surgery but the retina detached again.by the time i went in for another surgery the retina had crumpled,and after the surgery i could only see light and nothing else.are u able to restore my retina through stem cell surgery?

It is possible that stem cell therapy could help but you should seek the advice of a trained vitreo-retinal specialist. He or she can provide you with detailed information regarding the physical state of your retina and which, if any restorative treatments such as stem cells, visual prosthetics or optogenetics may be of value.

Please please let me know how my brother can enrol for trials, who is suffering from rp from past 10yrs. Can’t see my brother sulkin over d disease. Please reply whatever it is. Crossing my fingers n hoping to be one among them.

I have a father n law who has had his retna die almost completely. We are very interrested in finding out how to get excepted for the human trials. To see my father nlaw not be able to continue working due to this is very hard. He does what he loves to do and needs his eyes to do it. He is a veteran and we want him to be able to continue to work. Please let me know more about this and help him. Thank u.

Hi
iam 26 i have problem in optic nerve(atrophy)and retinitis pigmentosa.please help me.i want to candidate in your clinical trail.my prepheral vision has been destroyd compleletly and i have central vision just.
best regards

You should check the website: http://WWW.ClinicalTrials.gov for information on new clinical trials. You should also consider participating in FFB’s “My Retina Tracker”, a free registry that can help you find out about clinical trials that are recruiting for your specific disease. For more information on “My Retina Tracker” please see the following web link:https://www.myretinatracker.org/

I never see mention of anterior ischemic optic neuropothy in any stem cell liturature. Maybe I just don’t recognize the name of the damaged cells to associate an article. Please advise if there is any research in this area. Thanks.

Anterior ischemic optic neuropathy (AION) is a medical condition involving loss of vision due to damage to the optic nerve from insufficient blood supply. Ufortunately, the FFB does not support research on this particular condition.

Almost 40 years back l was diagnosed with what is now called Open angle glaucoma. Today implants have stabilized the pressure (7 to 9 in each eye)…..
However my vision continues to worsen. The fog is progressing.
A blind friend suggested l contact you and request to enter a clinical study of optic nerves or any other related research that you are engaged in.
I am desperate… and will do anything to save what vision remains.
Thanking you in advance l remain,
Bradford L. Tiffany

You may be interested to know that stem cell therapy is currently being evaluated for possible use in optic nerve damage. The research is slowly moving towards the clinic but will probably not be ready for clinical trials for a few more years. Dr. Dong Chen at Schepens’ Eye Institute is currently working in this area. To read more about his work, please see the following web link: http://www.schepens.harvard.edu/research-storychen/dong-feng-chen-md-phd/research-story.html

Hello – First of all, THANK GOD and ALL THE ONES WHO ARE WORKING HARD TO HELP OTHERS affected by this condition! My dad has gone completely blind within the past 4 years and he is patiently waiting for this type of treatment. We have been to many doctors, trying to find a cure or treatment for him, but they always tell us there is nothing they can do once the optic nerves are that damaged. I am praying today for a cure, and our entire family along with my dad, are hopeful that one day, soon, my dad can become part of one of these trials… this is his biggest dream. It is hard to see him being a prisoner of his own surroundings, so PLEASE CONTACT ME (ON HIS BEHALF) TO MAKE HIM PART OF THIS MIRACLE! THANK YOU AGAIN! — Claudia M. Poucher

I lost vision in my right eye from Glaucoma. I am interested in the research and treatment for Optic Nerve Regeneration. If there is an opening for patient Clinical Trial, I would be very interested in participating. Please send me any information available concerning Optic Nerve Regeneration and any scheduled Clinical Trials.
Thank you very much.

My nephew is 20 years old now and has optic nerve atrophy. He has completely lost vision on his right eye and his left eye is getting worse by day.
I want to know how can he get involved in clinical trials? Or is there any research getting done in this area?
Thank you.

Unfortunately, I am not aware of any treatment for NAION. However, there are currently 22 clinical trials that are recruiting patients that have NAION. Some of these trials involve experimental treatments and some of them are studying the natural progression of the disease. Here is the link to the Clinical Trials.Gov website: https://clinicaltrials.gov/ct2/results?term=naion&Search=Search

Unfortunately, I am not aware of any clinical trials utilizing stem cells for the treatment of wet AMD. The only clinical trials that I am aware of for AMD are for the “dry” form. Wet AMD accounts for about 10 percent of all cases of macular degeneration. Wet AMD is also called choroidal neovascularization (CNV), subretinal neovascularization, or exudative or disciform degeneration. In wet AMD, abnormal blood vessels grow beneath the macula. These vessels leak blood and fluid into the macula that damage photoreceptor cells. To read about FDA-authorized treatments for wet AMD, please see the following link: http://www.blindness.org/macular-degeneration/treatments
The government website: http://WWW.CLINICALTRIALS.GOV lists all of the “legitimate” clinical trials taking place. If you query in “wet AMD”, you will see approximately 67 trials that are recruiting patients for clinical trials. Here is the web link: https://clinicaltrials.gov/ct2/results?term=wet+amd&recr=Open&no_unk=Y
You will need to look at each trial to see whether or not you fit the inclusion and exclusion criteria. Some trials pay for travel and some do not. Each trial should list a phone number where you can call for more information. I hope this helps.

Did you find out anything for your daughter? My daughter has the same condition. We are in a tail spin. We are not sure what we should/can do. I met someone who claims hospitals in Chin do stem cell for optic glioma. Please let me know if you find anything. Thanks.

In October of 2014 I had an eye stroke in my left eye. My Retinal Specialist mention that there may be a solution in the near future due to current research. I am 48 years old. Please keep me informed of progress or possible solutions. Thank you.

Glad to hear and thankful to hear that research is going to try to help people with vision issues. i have RP and my vision is worsening now. I would be very interested in research and a clinical trial if there is one available to help me with my vision. Please contact me and keep me informed. Waiting for a miracle. My peripheral vision and night vision are very bad. With the worsening of sight my central vision is also decreasing. I know when God closes one door he does open another. I am hoping and praying that this could be the door opening for me with God working through others who are working to make this a reality for all who have been affected by vision issues.
Thank you so much for your efforts.
Deb

I am a 41 year old man that has been diagnosed w pseudo tumor ceribi. I have undergone two surgeries such as: bilateral optical nerve sheathing and also I now have a deep brain shunt. I am very interested in participating in the clinical study for optical nerve regeneration. Please contact me via email if this is an option for me. Thank you

You should check the website: http://WWW.CLINICALTRIALS.GOV which is maintained by the National Institutes of Health and contains a searchable list of clinical trials for most known diseases. Each clinical trial listing will provide you with information on what the study is about, the requirements for participating and contact information.

You may want to check the website: http://WWW.CLINICALTRIALS.GOV which is maintained by the National Institutes of Health and contains a searchable list of clinical trials for most known diseases. Each clinical trial listing will provide you with information on what the study is about, the requirements for participating and contact information.

If my daughter would be a candidate I can’t tell you how relieved this mama would be! She had a bad recent eye injury. We wait now 2 weeks exactly to see what our next steps maybe. There is too much blood in the front of the eye and the back of the eye to know yet what we are facing exactly. We do know light isn’t going into her injured eye at this point. Please feel free to email me if you think you can help her.

I have a friend who is I his forties and got into a bad accident 14 years ago and lost the ability to see. His optical nerve was damaged , his pressure is fine and can move his eyes. Can stem cell research help him?
Let me if there are clinical trials he can sign up for.

Hello
Now 2016, do you have any update for the Stem Cell Clinical Trial for Glaucoma? I am not sure that there is it succeeds in Clinical for human or not? Can any one update me the detail or send me more detail at r.suksan@gmail.com
Thanks
Suksan

My beautiful wife has pigmentary glaucoma and is almost blind now. It was a very aggressive form. We have 2 kids 9 & 11. I pray that stem cell therapy will be the answer! Can you please email me any research updates on this?
Thank you so much,
Paul

Stem cell therapy is currently being evaluated for possible use in optic nerve damage caused by glaucoma. The research is slowly moving towards the clinic but will probably not be ready for clinical trials for a few more years. Dr. Dong Chen at Schepens’ Eye Institute is currently working in this area. To read more about his work, please see the following web link: http://www.schepens.harvard.edu/research-storychen/dong-feng-chen-md-phd/research-story.html

I lost my vision in both eyes due to ischemic optic neuropathy after back surgery. I have not seen my children in 20 years. Can stem cell therapy regenerate the optic nerves? Please send any relevant information. I am also interested in clinical trials.

I have optic atrophy and have had since birth. I’m now 51 years old and have been looking for some help within the last few years. I went down to the Moorefield hospital London and was seen by Dr G Plant many times. I travelled to London several times within the last few years. Many Dr in the Quean Square hospital in London saw me also. They took muscle biopsies from me and completed many tests on me. There wasn’t any treatment they could give me for optic atrophy.

I come from a large family where I have 4 brothers and 5 sisters. I’m the only one with eye site problems.

When looking through my left eye, it is like looking through a frosted windo. When I was growing up I went to school where I was able to read and write intill I was around 16 years old. My eye site worsened afterwards where now I can’t read or write now.

I’m desperate for some help if there is anything that can be done for me. I can travel to anywhere and would like to be put forward for any research in the future.
If you can’t help, can you forward my details to anyone who can?

Dear Andrea, Stem cell therapy is currently being evaluated for possible use in optic nerve damage and may have some utility in treating optic nerve hypoplasia as well. The research is slowly moving towards the clinic but will probably not be ready for clinical trials for a few more years. Dr. Dong Chen at Schepens’ Eye Institute is currently working in this area. To read more about his work, please see the following web link: http://www.schepens.harvard.edu/research-storychen/dong-feng-chen-md-phd/research-story.html

My significant other is scheduled for total right eye removal at the end of the month due to painful blistered cornea – glaucoma has completely destroyed his optic nerve. With such advances being made with stem cell research, should he hold off in the hope of optic nerve regeneration?

Dear Jan, Individuals like your friends that have lost a substantial number of photoreceptors to disease may be able to benefit from several new sight restorative technologies that are currently being testing in human clinical trials. Currently, three promising technologies for sight restoration are: visual prosthetics, optogenetics and stem cell photoreceptor replacement therapy. To learn more about visual prosthetics, see the following link http://www.blindness.org/announcing-argus-ii-retinal-prosthesis-system . To learn more about optogenetics, please see the following web link:http://www.blindness.org/blog/index.php/arvo-update-on-optogenetics-new-light-for-people-with-advanced-vision-loss/. To learn more about stem cell therapy, see the following link: http://www.blindness.org/blog/index.php/stem-cell-research-moving-at-the-speed-of-light/. Your friends should consider participating in FFB’s “My Retina Tracker”, a free registry that monitors clinical trials that are recruiting for various retinal diseases. For more information on “My Retina Tracker” please see the following web link: https://www.myretinatracker.org/ . In addition, your friends may find it helpful to periodically check the website: http://WWW.CLINICALTRIALS.GOV which is maintained by the National Institutes of Health and contains a searchable list of clinical trials for most known diseases. Each clinical trial listing will provide you with information on what the study is about, the requirements for participating and contact information. Thank you for your support that is helping to accelerate the development of new safe and effective treatments for inherited retinal disease. A new treatment called optogenetics is now in human clinical trials by the company, Retrosense. People with RP become completely blind if they lose all of their photoreceptors, the cells in the retina that make vision possible. RetroSense’s optogenetic therapy restores vision by bestowing light sensitivity to retinal ganglion cells, which survive after photoreceptors are lost. Retinal ganglion cells normally don’t process light; rather, they perform image-processing functions downstream. RetroSense’s optogenetic treatment is a gene therapy, which uses a human-engineered adeno-associated virus (AAV) to deliver a gene to retinal ganglion cells that encodes channelrhodpsin-2, a light-sensing protein. To find out more about the Retrosense trial, please see the following weblink: https://clinicaltrials.gov/ct2/results?term=retrosense&Search=Search

I was wondering how can one possibly become apart of the trials. Most of my body is completely damaged due to sickness and sickness made worse through a bad diet as well as my baby. Can stem cells be used to repair nerve damage throughout the entire system?? If so can my kids and i become apart of the clinical trials?

Dear Wiloria, The Foundation Fighting Blindness funds many clinical trials but does not manage the studies and so reaching out to them directly may be the best way for you to find out more about where they are happening and if participating is an option. The website: http://WWW.CLINICALTRIALS.GOV is maintained by the National Institutes of Health and contains a searchable list of clinical trials for most known diseases. Each clinical trial listing will provide you with information on what the study is about, the requirements for participating and contact information. Most of the listings usually have a phone number for the clinical trial coordinator that you can call to get additional information.

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